Trials / Completed
CompletedNCT01760434
Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 30 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.
Detailed description
The investigators hypothesize that sagittal alignment and thoracic volumes will predict successful treatment outcomes as measured by improved pulmonary function and health-related quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up. Significant focus has been placed on the coronal plane in order to determine treatment indications for scoliosis, but with new understanding about the important of sagittal balance and pulmonary function, the treatment indications should be broadened. Thus, the investigators propose the following study to explore parameters associated with a durable and acceptable outcome following scoliosis treatment, minimizing the need for further surgery and to optimizing quality of life and pulmonary health. Beyond the standard radiographs and Scoliosis Research Society (SRS) scores, this study undertakes a comprehensive assessment of health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane parameters, and 3D modeling of the childhood and current spinothoracic deformity. Thus, the investigators research team is uniquely poised to determine broader treatment indications for scoliosis. The overarching goal of this research effort is to determine new parameters based on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to determine the appropriate treatment threshold for surgical intervention in children with adolescent idiopathic scoliosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Long-term outcomes | Patients with a history of adolescent idiopathic scoliosis will return at a minimum of 20 year follow-up for new spine xrays, clinical exam, pulmonary function testing, and assessment of health related quality of life based on survey responses. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2013-01-04
- Last updated
- 2019-03-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01760434. Inclusion in this directory is not an endorsement.